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Murray,
Utah84143

Purpose:

Each patient who is admitted for preoperative preparation for elective open heart surgery at
Intermountain Medical Center will be invited to participate in this study. After a written
informed consent is obtained, patients meeting inclusion/exclusion criteria will be
randomized 1:1 to the treatment arm or placebo/control arm. Those randomized to the treatment
arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose
will be given the evening before surgery. The second and third doses will be given either
orally or per NG tube on the mornings of post-op days 1 and 2. Blood will be obtained at the
following time periods: 1) At baseline pre-procedure 12 to 18 hours before planned surgery;
2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4) 72 hours
after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and 6) At
the 6-month follow-up visit (post-surgery). Plasma levels of 25(OH) vitamin D will be
measured on each sample.

Study summary:

Each patient who is admitted for preoperative preparation for elective open heart surgery at
Intermountain Medical Center will be invited to participate in this study. The patient's
history and medical records will be reviewed and data gathered will be used to evaluate the
patient's relationship to inclusion and exclusion criteria. After a written informed consent
is obtained, subjects will be randomized 1:1 to the treatment arm or placebo/control arm.
Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3
supplementation. The first dose will be given the evening before surgery. The second and
third doses will be given either orally or per NG tube on the mornings of post-op days 1 and
2. Approximately 15-20 ml (about one tablespoon) of blood will be obtained at the following
time periods (+/- 4 hours): 1) At baseline pre-procedure 12 to 18 hours before planned
surgery; 2) Post-operative day 1, 12 to 24 hours after surgery; 3) 48 hours after surgery; 4)
72 hours after surgery; 5) At discharge (estimated to be between 5-8 days after surgery); and
6) At the 6-month follow-up visit (post-surgery). Each blood sample will be transported to
The Center for Molecular and Genetic Research at LDS Hospital Cardiovascular Genetics
Laboratory for preparation and storage. Plasma levels of 25(OH) vitamin D will be measured on
each sample.

Criteria:

Inclusion Criteria:
1. Male or female >= 18 years of age
2. Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of any study procedures
3. Subject is scheduled for elective open heart surgery at Intermountain Medical Center
4. Subject is relatively stable as assessed by the Principal Investigator
Exclusion Criteria:
1. Inability or refusal of the patient and/or the patient's legally acceptable
representative to provide written informed consent for any reason.
2. History of previous vitamin D supplementation > 1,000 units of vitamin D3 per day
within the past three months.
3. Evidence of hypercalcemia on screening labs (> 10.5 milligrams per deciliter of
blood).
4. Any scheduled cardiac surgical procedure that does not require open thoracotomy (the
reason for this exclusion is that the study design requires that the patients will
undergo a significantly stressful procedure, which can be generally guaranteed if the
patient undergoes open thoracotomy).
5. Known allergic reaction or other intolerance to oral vitamin D3.
6. Pregnant and/or lactating women and women of child bearing potential who are not using
acceptable means of contraception. Women of childbearing potential must be using
adequate measures of contraception (as determined by the Principal Investigator) to
avoid pregnancy and should be highly unlikely to conceive during the study period.
Women of childbearing potential must have a negative pregnancy test at screen.
7. Subject participation in previous investigational interventional studies within 30
days of the current study.
8. Other conditions that in the opinion of the Principal Investigator may increase risk
to the subject and/or compromise the quality of the clinical trial.